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Dear all
In Bioequivalence studies, do we need to store the reference standards
in controlled temperature and humidity and monitor them over 24 hours
or can they be handled under ordinary working area conditions. Do we
need also to track the use of these standards?
Regards
Isra
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Isra, regarding stability of standards,
You should separately determine the stability of the standards on the
carosel of the instrument, and then however you plan to store them in
the laboratory over 24 hours and over several days, and also of any
stock solutions if you plan to store them. These determinations need
planning, but are easy to do: prepare the standards, put some in the
instrument and store some in the laboratory and then run them the next
day against freshly prepared standards, and then run them again a few
days later with newly prepared standards.
You must track the use of all standards.
Frank Bales,
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Here at the Bio-pharmaceutics research laboratory Rhodes university
South Africa any working standard (internal standard or working
calibration curve samples) is usually stored in a refrigerator to
avoid decomposition.
Well you can check this practically. Store some of your standards
under normal working conditions and some in a refrigerator.
Monitor the peak height ratio,s or peak area for two weeks and note
the difference.Come up with a good protocol to Keep your standards.
s.o.o
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